Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS

K-Number: K945371 · 1995-04-27

ApplicantStandard Textile Co., Inc.
Decision Date1995-04-27
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 1995-04-27 under 510(k) number K945371. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS?

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K945371.

When did COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS receive FDA 510(k) clearance?

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS received FDA 510(k) clearance on 1995-04-27, under 510(k) number K945371.

Who is the listed applicant for COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS?

The FDA 510(k) record lists Standard Textile Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS?

The FDA product code for COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS is FYA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Standard Textile Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241214ProPel SG3™ Surgical GownK172207Standard Supreme Sterilization WrapperK162162Barrier Supreme Sterilization WrapperK060181COMPE1 1 -PLY SURGICAL GOWNSK041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSK041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

View all 23 devices →

Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑